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About Us
OLPHARM - R&D and Expertise Center
OLPHARM is a team of experts with more than 20 years of experience in the field of pharmaceuticals, representing a wide variety of specializations: doctors, pharmacists, scientific researchers, regulatory and marketing specialists.
We have deep expertise in the development and testing of new drugs, production and quality control, as well as the regulatory sphere.
We are ready to assist manufacturing companies and distributors of medicines in developing an effective strategy for managing the life cycle of a product (drugs, dietary supplements, medical devices), ensuring its high quality and safety, as well as ensuring your success in the market of pharmaceuticals, dietary supplements and medical devices.
Regulatory and technological expertise
We will study all the requirements that apply to the product and its documentation. This may include a list of documents, data that must be specified in the application for research, as well as requirements for laboratory and clinical trials.
Data collection and analysis
We will collect all the necessary information about the product, including composition, production technology, product stability and safety. Data analysis will help to identify possible problems and deficiencies of the product that may affect its registration.
Laboratory studies
We will carry out all the necessary laboratory studies, for example, analysis of the chemical composition of the product, tests for safety and toxicity, analysis of microbiological properties, etc.
Clinical and preclinical studies
We organize all the necessary studies to confirm safety and efficacy.
Preparation of documentation
After collecting and analyzing all the data, we will develop all the necessary documentation, which will be included in the registration dossier. This may include product descriptions, laboratory and clinical study protocols, manufacturing process details, instructions for use, etc.
Submission of an application
after compiling the documentation, we will submit an application for registration of the product to the appropriate registration authority and provide all the necessary documents.
Waiting for a decision
After submitting an application, we will revise the documents and ensure that a decision is made on product registration.
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OLFARM LLC is an independent accredited laboratory and research center. The scope of accreditation of the testing laboratory includes a wide range of physicochemical, microbiological, virological and biological methods.
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